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Supplier controls may get closer review under possible QSIT change

This article was originally published in The Silver Sheet

Executive Summary

FDA may change its Quality System Inspection Technique (QSIT) to place more emphasis on the auditing of supplier controls, an agency official says. "Purchasing controls is something that right now is very, very timely," Jan Welch, a consumer safety officer in CDRH's Office of Compliance, said at a Global Harmonization Task Force (GHTF) conference Oct. 4 in Washington, D.C. "FDA is giving consideration to revising QSIT, thinking about where purchasing controls might have a more elevated, heightened awareness within QSIT. That's a very, very good thing." Manufacturer problems with outsourcing and supplier controls also is emerging as a hot-button issue for GHTF, which has tasked its Study Group 3 with creating a purchasing control guidance expected to be released in draft form this fall

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